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FDA Approves INTUNIV (guanfacine) for the Treatment of ADHD

Shire announced today that it has received an approvable letter from the US Food and Drug Administration (FDA) for INTUNIV (guanfacine) extended release tablets (previously referred to as SPD503), a nonstimulant selective alpha-2A-receptor agonist, which has been studied in children and adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD). Unlike some other ADHD treatments, INTUNIV, a nonstimulant, is not a controlled substance and does not have a known mechanism for potential abuse or dependence. The information requested by the FDA was not unexpected, and Shire is working with the FDA to provide a full and timely response to the agency's request.

"The FDA's approvable letter for INTUNIV is positive news, and Shire will be working closely with the agency to address its questions," said Matthew Emmens, CEO of Shire. "When approved, INTUNIV will be the first medication indicated to treat ADHD symptoms by selectively targeting alpha-2A-receptors in the prefrontal cortex, an area of the brain that is thought to manage executive functioning tasks. Shire is looking forward to further strengthening our broad portfolio of ADHD medications by adding a nonstimulant treatment option with a novel mechanism of action and demonstrated clinical efficacy, which may be ideal for those patients who have not benefited from currently available ADHD medications." About INTUNIV (guanfacine) Extended Release Tablets Shire is seeking approval of INTUNIV as monotherapy for the treatment of ADHD symptoms throughout the day in children aged 6 to 17 years, with dosage strengths of 1 mg to 4 mg daily. The INTUNIV New Drug Application (NDA) includes data from two placebo-controlled trials in children and adolescents ages 6 to 17 evaluating the compound's safety and efficacy in controlling ADHD symptoms evaluated on a once-weekly basis using the ADHD Rating Scale (ADHD-RS-IV), which included both hyperactive/impulsive and inattentive subscales. ADHD-RS-IV i
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